RU2732111C2 - Bag for sterile product solution - Google Patents

Abstract

FIELD: bags for sterile solution.

SUBSTANCE: bag filling bag for sterile product solution contains multiple chambers in fluid connection to each other by means of tubes system; a rod having an end with an inlet and an end with an outlet, the end with the rod outlet being in fluid communication with the plurality of chambers; and a filter arranged coaxially to the rod, which has at least one filter membrane with a nominal pore size in range of 0.1 to 0.5 mcm, and a rod and a filter, in fluid connection with a system of tubes and a plurality of chambers for filling a bag filling bag for a sterile solution product. Tube system consists of a first portion extending from the rod and a plurality of second portions extending from the first portion to the plurality of chambers. Set for bag filling for sterile product solution. Also disclosed is a version of bag filling kit for sterile product solution.

EFFECT: group of inventions enables filtration of microorganisms and solid particles using said filter directly at the filling point.

29 cl, 24 dwg

Description

CROSS-REFERENCE TO RELATED APPLICATION

[00001] Priority is claimed on US Provisional Patent Application No. 62 / 281.799, filed January 22, 2016 and titled "Sterile Product Solution Bag", and the entire contents of such application are incorporated herein by reference.

FIELD OF TECHNOLOGY

[00002] The disclosed information relates to a sterile product solution bag, and in particular a sterile product solution bag having a built-in filter to filter out microorganisms and particulate matter during filling in an unconventional setting.

TECHNOLOGY LEVEL

[00003] Traditional methods of making bags of sterile solution include filling the bags with a solution in a clean environment, sealing the filled bag with the solution, and then sterilizing the liquid and bags in a sterilization autoclave. This can be called terminal sterilization. Another traditional method is: passing the solution through a sterile filter; filling and sealing sterile bags in an extremely high quality environment designed and controlled to prevent contamination of the solution during the filling process; and sealing the filled bag. This can be called aseptic filling process.

[00004] Final sterilization usually requires autoclaves to obtain the heat and steam required for sterilization. These autoclaves are generally not economical unless they can produce large batches of final sterilized bags. Thus, the required capital costs and space requirements lead to the use of centralized production facilities that produce filled bags and then send them some distance to the destinations where they will be used. In addition, the use of terminal sterilization processes can cause deterioration in the quality of the solution formulation, resulting in incompatible or unstable chemical formulations. Moreover, terminal sterilization does not eliminate non-viable particulate contamination.

[00005] The aseptic manufacturing process must take place in a sterile work environment and requires a wide range of equipment, rigorous procedures and full monitoring to ensure that product solution bags meet specific environmental and manufacturing regulations. Sterilizing a work environment can itself be costly and time consuming. Technicians involved in the filling process must take additional precautions to ensure that the product is safe and sterile. Even with these precautions, if it is not possible to check and ensure that the solution that enters the bag is sterile, there is a risk that contaminants may accidentally enter the solution during filling / sealing, and after entering the solution, contaminants remain in the bag. it if the solution is not subsequently passed through an acceptable sterilizing filter. Again, due to such requirements, bags of sterile product solutions are often produced in centralized facilities and sent some distance to the destinations where they will be used.

[00006] Taking into account the costs associated with the production of bags for sterile solution of the product, most medical centers and clinics order the production of the number of sterile bags they need from manufacturing companies. To maintain sterility during transport, bags for sterile products must be carefully packed to ensure safe delivery. For this reason, purchasing sterile product bags at a remote location can be very expensive and can increase the risk of contamination.

SUMMARY OF THE INVENTION

[00007] The present invention relates to a bag for a sterile product solution containing an in-line sterilization grade filter capable of filtering out microorganisms and particulate matter using this filter directly at the point of filling. The filter / container combination is pre-sterilized to a US (Sterility Level) ≤ 10 ^-6 before filling. The advantage of integrating the filter and the final container is that the filters can be sterilized after being connected to the final container so that there is minimal or no risk of contamination of the solution after filtration. An additional advantage of this approach is that there is no requirement for a strictly controlled and closed filling environment, which makes it possible to use a very simplified filling environment that can be created in various non-traditional conditions (for example, in pharmacies, at patient's homes, etc.). In some embodiments, the product bag (s) of the present invention may be filled using an automated or semi-automated filling machine / system, such as those disclosed in US Provisional Patent Application No. 62 / 281.825 entitled "METHOD AND MACHINE FOR PRODUCING BAGS FOR STERILE PRODUCT SOLUTIONS ”filed January 22, 2016, the entire content of which is expressly incorporated herein by reference. In addition, the size of the filter can be reduced due to the limited volume handled by each filter, thereby reducing the size and cost of each filter.

[00008] Embodiments within the scope of the present invention are directed to a product bag, the entire interior of which is pre-sterilized and contains: a chamber, a rod, a filter and a sterile closure cap. The chamber is a refillable bag of standard capacity with a pre-posterized internal environment. The chamber is in fluid communication with the rod through an opening at the first end of the chamber. The injection and medication ports are located at the second end of the chamber.

[00009] In some embodiments within the scope of this invention, the rod is a narrow tube that fluidly connects the inlet of the rod to the opening of the chamber. The rod may have a tapered head defining the inlet, a sleeve connecting the first part of the stem to the tapered head, a second part, and a tube defining the outlet of the stem. The sterile closure cap may have a hemispherical protrusion attached to the stem of the stem, which creates a sealable cover at the stem inlet.

[00010] In some embodiments within the scope of the present invention, the filter includes a flat membrane filter plate or hollow fiber membrane that is aligned with the rod between the first and second rod portions. The tapered stem head can be a female end fitting that seals with a Luer fitting. With this configuration, the solution can enter through the inlet of the rod and pass sequentially through the head into the first portion towards the inlet of the filter. The solution is then filtered through the filter membrane, exits through the filter outlet and into the second part of the rod. The tube provides a fluid connection of the filtered solution from the second part and the chamber opening. The second rod portion, defined as the area of the rod between the filter outlet and the tube inlet, may be referred to as the cutting and sealing portion. The rod provides an isolated fluid connection between the inlet and the chamber so that after filtration of the solution through the membrane, the filtered solution enters directly into the sterilized environment of the chamber.

[00011] In other embodiments within the scope of the present invention, the rod, which may be tapered or cylindrical, does not provide separate filter connection ports at the inlet and outlet. Instead, the filter includes a hollow fiber filter membrane that conforms to the shape of the rod. In some embodiments, within the scope of the present invention, a set of redundant filters in series in a rod may be used in conjunction with a product bag. In some embodiments within the scope of the present invention, one or more looped hollow fiber filter membranes may be secured within the filter housing to provide faster filtration. In other embodiments within the scope of the present invention, a plurality of hollow fiber filter membranes may be disposed side-by-side or in a circle to form a coherent configuration allowing for faster filtration.

[00012] In some embodiments within the scope of the present invention, product bags may be configured to use a single filter to process a solution from multiple product bags. For example, multiple product chambers can be positioned in a belt-like configuration and connected to a single filter, with the filtered solution filling the chambers in series. Alternatively, multiple chambers can be connected with a tight-fitting tubing system to one filter.

[00013] Each filter is a sterilization grade filter and contains a suitable sterilization grade material having multiple pores; the filter has a nominal pore size in the range of about 0.1 micron to about 0.5 micron, such as about 0.2 to about 0.4 micron. In some embodiments, each pore has a diameter less than or equal to about 0.2 microns. In some embodiments, each pore has a diameter less than or equal to about 0.22 microns. In some embodiments, the filter has a nominal pore size ranging from about 0.1 micron to about 0.2 micron. In some embodiments, the filter has a nominal pore size ranging from about 0.1 micron to about 0.22 micron. When characterizing the porosity of filter membranes, “nominal pore size” generally refers to the diameter of the smallest particle that cannot pass through the membrane. Porosimetry is commonly used to determine the nominal pore size. Most membrane filter manufacturers characterize their filters on the first bubble point (FBP) as defined in the American Society for Testing Materials ASTM F-316-03 (2011) Standard Test Methods for Pore Size Characteristics of Membrane Filters by Point of Gas and by Testing for average flow through the pore ". The nominal pore size is calculated from the FBP using the Young-Laplace formula P = 4 * γ * cos θ * / D, where D is the pore diameter, P is the measured pressure, γ is the surface tension of the wetting liquid, and θ is the angle of contact of the wetting liquid with the sample. In one test, a suitable flow rate for measuring FBP would be about 30 ml / min.

[00014] A filter of this design effectively sterilizes and reduces the level of solids in the solution as the solution passes through the filter and into the chamber. Filling of the product bag can be carried out at temperatures above 60 ° C for formulations that are compatible, so that the residual risks of microbial contamination from living organisms passing through the filter are further reduced by pasteurization or similar heat treatment in addition to filtration. Alternatively, hot filling can be replaced by a sterilization process just prior to filling such as UV sterilization, heat sterilization, electron beam sterilization, and the like.

[00015] In some embodiments, the filter configurations disclosed herein may be connected to a dual-bag continuous ambulatory peritoneal dialysis (CAPD) container system. The CAPD container system with two bags allows the administration of solutions important for peritoneal dialysis to patients with end-stage renal disease in places where treatment of such patients might not otherwise be possible. The two-bag container system includes a solution bag and a drainage bag. The solution bag may have an injection field for medicinal additives. The tubing runs from the solution bag and drainage bag to the patient connector. The patient connector mates with the patient's peritoneal dialysis (PD) catheter transfusion system during use. The patient connector may have a tee to which the tubing is connected. The tubing from the solution bag to the patient connector may have a fragile portion just in front of the patient connector. The patient connector may have a protective cap to ensure sterility, which can be removed immediately prior to use. In some embodiments, the filter may be configured to connect at the filter tee to tubing from the solution bag to the patient connector. In other embodiments, the filter may be configured to be connected to the solution bag by means of tubes that are completely separate from the tubing from the solution bag to the patient connector.

[00016] According to a first independent aspect, a bag for a sterile product solution is provided, including a chamber, rod, and filter. The rod has an inlet end and an outlet end, the outlet end of the rod is in fluid communication with the chamber. The filter is coaxial to the rod, the filter has a filter membrane with a nominal pore size in the range of about 0.1 μm to about 0.5 μm, the filter membrane is in the form of a hollow fiber with pores located in the fiber wall.

[00017] In a second aspect according to the previous aspect, a filter membrane is disposed within the rod between the inlet and outlet edges.

[00018] In a third aspect, according to the previous aspects, the filter comprises a plurality of filter membranes.

[00019] In a fourth aspect according to the previous aspects, the outlet end of the hollow fiber of the filter membrane is sealed, and the inlet end is an open inlet.

[00020] In a fifth aspect, according to the previous aspects, the filter membrane has a wall thickness in the range of about 150 microns to about 500 microns.

[00021] In a sixth aspect, according to previous aspects, the filter membrane has a longitudinal dimension in the range of about 3 cm to about 20 cm, an inner diameter in the range of about 2 mm to about 4 mm, and an outer diameter in the range of about 2.3 mm to about 5 mm.

[00022] In a seventh aspect according to the previous aspects, the filter membrane is made from at least one of the following materials: polyolefin, polyvinylidene fluoride, polymethyl methacrylate, polyacrylonitrile, polysulfone, polyethersulfone, and a polymer containing cation charges.

[00023] In an eighth aspect, according to the previous aspects, the rod is either flexible or rigid.

[00024] In a ninth aspect, according to the previous aspects, the rod is made of at least one of the following materials: PVC, PET, poly (meth) acrylate, polycarbonate, polyolefin, cycloolefin copolymer, polystyrene, or silicone polymer.

[00025] In a tenth aspect according to previous aspects, the filter includes at least one U-shaped hollow fiber filter membrane secured in a U-shaped configuration by a filter membrane body disposed within the filter body.

[00026] In an eleventh aspect, according to the previous aspects, the filter comprises a plurality of U-shaped hollow fiber filter membranes.

[00027] In a twelfth aspect, according to the previous aspects, the filter is composed of a plurality of parallel hollow fiber membrane filters fixed in a side-by-side configuration.

[00028] In a thirteenth aspect according to the previous aspects, the filter is composed of a plurality of parallel hollow fiber membrane filters arranged in a circle.

[00029] In a fourteenth aspect, according to the previous aspects, the filter membrane has a nominal pore size in the range of about 0.1 microns to about 0.22 microns.

[00030] In a fifteenth aspect according to the foregoing aspects, the sterile product solution bag is composed of a plurality of chambers in direct fluid communication with each other, a rod and a filter connected to the plurality of chambers for filling the product bag, each chamber being connected to at least at least one other chamber along the edge between the chambers, and each edge has an opening through which a fluid connection of these chambers is provided, and a single filter is connected to one of the chambers through an inlet.

[00031] In a sixteenth aspect according to the previous aspects, the bag for the sterile product solution comprises a plurality of chambers in fluid communication with each other through a tight-fitting tubing system, a rod and a filter connected to the plurality of chambers for filling the product bag, the tight-fitting system of tubes consists of a first part that goes up to the connection and a plurality of second parts that go from the connection to a plurality of chambers, every second part going to one chamber.

[00032] In accordance with a seventeenth independent aspect, a sterile product solution bag is provided comprising a chamber, a rod, and a filter. The rod has an inlet end and an outlet end, the outlet end of the rod is in fluid communication with the chamber. The filter includes a porous filter membrane located within the rod, the filter membrane being a hollow cylinder with a closed end located between the inlet and outlet rod ends and an open end located in close proximity to the inlet rod end. The connector is connected to the inlet end of the rod and to the open end of the filter; the connector has a solution inlet, a solution outlet, and a sealing surface disposed between the solution inlet and the solution outlet; the solution outlet is connected to the open end of the filter, and the sealing surface is connected to the inlet end of the rod; the solution inlet is adapted to receive the solution for filtration through the rod and into the chamber.

[00033] In an eighteenth aspect according to the previous aspects, the porous filter membrane has a nominal pore size in the range of about 0.1 microns to about 0.5 microns.

[00034] In a nineteenth aspect, according to the previous aspects, the filter membrane has a nominal pore size in the range of about 0.1 microns to about 0.22 microns.

[00035] In a twentieth aspect according to the previous aspects, the inlet rod end is attached to the sealing surface of the connector, and the open end of the filter is attached to the solution outlet of the connector.

[00036] In a twenty-first aspect according to the previous aspects, the connector outlet is comprised of a cylindrical member disposed within an open end of the filter.

[00037] In a twenty-second aspect according to previous aspects, the filter comprises a plurality of filter membranes.

[00038] In a twenty-third aspect according to previous aspects, the filter membrane has a wall thickness in the range of about 150 microns to about 500 microns.

[00039] In a twenty-fourth aspect according to the previous aspects, the filter membrane has a longitudinal dimension in the range of about 3 cm to about 20 cm, an inner diameter in the range of about 2 mm to about 4 mm, and an outer diameter in the range of about 2.3 mm to approx. 5 mm.

[00040] In a twenty-fifth aspect according to the previous aspects, the filter membrane is made of at least one of the following materials: polyolefin, polyvinylidene fluoride, polymethyl methacrylate, polyacrylonitrile, polysulfone, polyethersulfone, and a polymer containing cation charges.

[00041] In a twenty-sixth aspect, according to the previous aspects, the rod is either flexible or rigid.

[00042] In a twenty-seventh aspect according to the previous aspects, the rod is made of at least one of the following materials: PVC, PET, poly (meth) acrylate, polycarbonate, polyolefin, cycloolefin copolymer, polystyrene, or silicone polymer.

[00043] In a twenty-eighth aspect according to the previous aspects, the bag for sterile product solution is part of a container system for performing continuous ambulatory peritoneal dialysis (CAPD) with two bags, which, in turn, consists of a drainage bag and a patient connector with a tee connected to a first tubing connected to the product bag; and a second tubing connected to a drainage bag.

[00044] In a twenty-ninth aspect, according to the previous aspects, an injection field is provided on the product bag.

[00045] In a thirtieth aspect according to the previous aspects, the first tubing connected to the product bag has a fragile portion.

[00046] In a thirty-first aspect according to the previous aspects, the patient connector has a protective cap to ensure sterility.

[00047] In a thirty-second aspect according to the previous aspects, the stem outlet is connected to a tee located along the first tubing connected to the product bag.

BRIEF DESCRIPTION OF THE GRAPHIC MATERIALS

[00048] While the specification concludes with claims particularly indicating and clearly stating the subject matter deemed disclosed herein, it is believed that the information thus disclosed may be better understood based on the following description in conjunction with the accompanying drawings. Some of the figures may have been simplified by omitting selected items to display other items more clearly. Such omissions of elements in some figures do not necessarily indicate the presence or absence of specific elements in any of the exemplary embodiments, unless otherwise clearly indicated in the associated written description. None of the drawings are necessarily drawn to scale.

[00049] FIG. 1 illustrates a front view of a product bag with a flat membrane filter plate coaxial to the core of the product bag in accordance with the teachings of the present invention.

[00050] FIG. 2 illustrates a side view of the product bag of FIG. 1.

[00051] FIG. 3 illustrates a front view of a product bag having a hollow fiber filter membrane coaxial to the core of the product bag in accordance with the teachings of the present invention.

[00052] FIG. 4 illustrates a side view of the product bag of FIG. 3.

[00053] FIG. 5 is an exploded isometric view of the filter and rod illustrated in FIG. 3 and 4.

[00054] FIG. 6 illustrates a perspective view of an alternative connector for use with a filter and rod such as the one illustrated in FIG. 3-5.

[00055] FIG. 7 illustrates a cross-section of the connector of FIG. 6.

[00056] FIG. 8 illustrates a side view of the connector of FIG. 6.

[00057] FIG. 9 illustrates a bottom view of the connector of FIG. 8.

[00058] FIG. 10 illustrates a top view of the connector of FIG. 8.

[00059] FIG. 11 is a front view of a product bag filter having a single looped hollow fiber membrane contained within a filter housing.

[00060] FIG. 12 is a front view of a product bag filter having a plurality of looped hollow fiber membranes contained within a filter housing.

[00061] FIG. 13 illustrates a front view of a plurality of hollow fiber membranes secured side-by-side.

[00062] FIG. 14 is an isometric view of an attachment device used for the plurality of hollow fiber membranes illustrated in FIG. 13.

[00063] FIG. 15 is an isometric view of a fiber bundle for a product bag having a plurality of hollow fiber membranes secured in an annular holder.

[00064] FIG. 16 is an exploded perspective view of an alternate connector for use with a three filter harness.

[00065] FIG. 17 is an exploded side view of the connector of FIG. sixteen.

[00066] FIG. 18 is an exploded perspective view of yet another alternative connector for use with a seven filter harness.

[00067] FIG. 19 is an exploded side view of the connector of FIG. 18.

[00068] FIG. 20 illustrates a bottom view of the connector of FIG. nineteen.

[00069] FIG. 21 illustrates a front view of multiple product bags with tight-fit connections in a belt configuration coupled to a single filter.

[00070] FIG. 22 illustrates a front view of multiple bags of product connected by a tight-fitting tubing system to a single filter.

[00071] FIG. 23 illustrates a front view of a continuous ambulatory peritoneal dialysis (CAPD) container system with two bags attached to one of the filter configurations disclosed herein by means of an asymmetric tee in a tubing system extending from the solution bag of the system to the patient connector of the system; and

[00072] FIG. 24 illustrates a front view of a continuous ambulatory peritoneal dialysis (CAPD) container system with two bags attached to one of the filter configurations disclosed herein via straight tubing extending from the system solution bag to the filter configuration.

DETAILED DESCRIPTION OF THE INVENTION

[00073] Referring to the figures in detail, FIG. 1 and 2 illustrate a product bag 100 having a pre-sterilized interior and including a chamber 102, a shaft 104, a filter 106 aligned with the shaft 104, and a sterile closure cap 108. Chamber 102 is a standard container refillable bag with a pre-sterilized interior. environment. At least partially surrounding the perimeter of the bag to be filled is a sealed edge 110 having a plurality of openings 112 configured to receive fastening pins for suspension during filling, insertion and / or storage. Chamber 102 is in fluid communication with stem 104 through opening 114 at first end 116 of chamber 102. Administration and medication ports 118, 120 are located at second end 122 of chamber 102.

[00074] The stem 104 is a hollow narrow tube with an inlet 124 in fluid communication with the opening 114 of the chamber 102. The stem 104 includes a tapered head 126 defining an inlet 124, a sleeve 128 connecting the first portion of the stem 130 to the tapered head 126, a second portion 132, and a tube 134 defining a rod outlet 136. The sterile closure cap 108 has a hemispherical protrusion 138 attached to a neck 140 that seals the inlet 124 of the stem 104. The cone 126 may be a female end fitting adapted to seal with a Luer lock fitting of a fluid line during filling, for example ... A filter 106 having a flat membrane plate 142 is disposed coaxially with the rod 104 between the first and second portions 130, 132 of the rod 104. Non-limiting examples of suitable filter membranes for filter membrane 142 are disclosed in U.S. Patent Publication No. 2012/0074064 A1 and PCT Publication PCT / EP2015 / 068004, the entire contents of which are incorporated herein by reference.

[00075] With this configuration, the solution can pass through the inlet 124 of the rod 104 and pass through the head 126 and into the first portion 130 towards the inlet 144 of the filter 106. The solution is then filtered through the filter membrane 142, exits the outlet of the filter 146 and into the second a portion 132 of the rod 104. Through the tube 134, the filtered solution flows from the second portion 132 into the opening 114 of the chamber 102. The second portion 132 of the rod 104, defined as the region of the rod between the outlet of the filter 146 and the inlet 148 of the tube 134, may be referred to as the "sealing area and cutting off ”. The phrase “sealing and cutting area” refers to the method by which product bags are sealed and cut off after filling. That is, the disclosed configuration has a structure in which, after the chamber 102 has been filled, the sealing mechanism can be activated to seal the rod 104 closed at the “seal and cut section” located below the filter membrane 142 but above the chamber 102. Thus, the “sealing section and cut "132 in this version is the portion of the rod 104 above the chamber 102 where the filter 106 is not present. Sealing of the "seal and cut" 132 may be accomplished with a heat seal or any other device, including, for example, applying a clip to the "seal and cut" 132. Once the stem 104 is sealed, the stem 104 is cut over the seal, but under the filter membrane 142, using a knife or any other device. The rod 104 provides an insulated fluid connection between the inlet 124 and the chamber 102 such that after filtration of the solution through the filter membrane 142, the filtered solution enters directly into the sterilized environment of the chamber 102. Thus, after the chamber 102 is filled and the rod 104 is sealed and cut off, the solution in chamber 102 remains sterile until chamber 102 is punctured or otherwise compromised. This, of course, assumes that filter 106 has not deteriorated prior to filling and that the filter is performing as expected.

[00076] To ensure that the filter 106 is working as expected, an integrity test of the filter 106 can be performed. The integrity test of the filter is facilitated by the formation of a "seal and cut" (second portion 132) of rod 104, which allows the filter membrane 142 to be separated from the rest of the now sealed product bag 100 without damaging it. For example, after the rod 104 and filter 106 have been separated from the product bag 100, the filter tester (not shown) may be pre-programmed or controlled to test the filter 106 for integrity. Examples of filter integrity tests may include a bubble test, a pressure degradation test, a water penetration test, a water spill test, or any suitable test known to those of skill in the art. The pressure degradation test is a way to check the quality of the filter before or after use. In the preferred embodiment, the filter 106 is tested after the solution has passed through the filter membrane 142 and into the chamber 102 of the product bag 100. To test the filter for integrity using a pressure degradation test procedure, a test head (not shown) encloses the rod 104 and applies air pressure a predetermined value at inlet 124 and filter membrane 142. In one embodiment, this predetermined value is the pressure at which gas cannot penetrate through filter membrane 142 of an acceptable filter 106. A pressure sensor or other device for measuring filter integrity is located inside the test head and measures the pressure drop or diffusion rate through the filter membrane 142. The integrity test results are evaluated to determine the quality of the filter 106 and therefore the quality of the solution that previously passed through the filter 106 and into the product bag 100. If the sensor d The pressure drop measures a pressure drop or an unexpected rate of drop, which means the filter 106 has failed the test and it can be determined that the solution in the product bag is unsatisfactory. Alternatively, during the bubble test, the test head gradually increases the pressure applied to the filter 106 and the pressure increase is measured in parallel with the diffusion rate of the gas through the filter membrane 142. Any disproportionate increase in the diffusion rate relative to the pressure applied may indicate the presence of a hole or otherwise. structural defect in the filter membrane 142 and the filter will fail the integrity test.

[00077] Thus, it should be appreciated that the disclosed "seal and cut" configuration 132 of the product bag 100 disclosed herein provides an advantage and simplifies filter integrity testing, as well as a high probability of determining whether the solution in the filled product bag is sterile, or there is a possibility that its sterility has been compromised.

[00078] An alternative product bag 150 illustrated in FIG. 3-5, includes a similar chamber 152 and a sterile closure cap 154 as in the first product bag 100. FIG. 3-5 product bag 150 contains a filter 155 consisting of a filter membrane 170 disposed within (i.e., at least partially or completely within) a rod 156. The rod 156, which may be tapered or cylindrical, does not provide separate inlet and filter outlet connection ports 155, as illustrated in the case of product bag 100 in FIG. 1 and 2. Instead, as illustrated in FIG. 5, the filter 155 is a hollow fiber membrane with one sealed end 158 and one open end with an inlet 160. The multiple pores 162 on the surface 164 of the filter 155 allow the pharmaceutical solution that enters the filter 155 through the open end with the inlet 160 to exit the filter 155. In one embodiment, the rod 156 surrounds the filter membrane 170 as a whole in a concentric configuration such that the filtered pharmaceutical solution exiting the filter membrane 170 is held within the rod 156 and ultimately moves into the chamber 152. Again, as illustrated in FIG. 1 and 2, the product bag of FIG. 3-55 includes a "seal and cut section" 132 below the filter 155 and above the chamber 152, the "seal and cut section" 132 facilitating the separation of that portion of the rod 156 containing the filter membrane 170. Due to the existence of the "seal and cut section" 132 the filter membrane 170 can be detached without compromising its integrity. As described above with respect to FIG. 1 and 2, this "seal and cut" portion 132 may provide an advantage by simplifying the integrity test of the filter 155.

[00079] As illustrated in FIG. 5, the hollow connector 166 can be used to secure the rod 156 and the filter 155 together. The open end with the inlet 160 of the filter 155 is sealed to the open end with the outlet 168 of the hollow connector 166. The connection may be achieved by gluing the open end with the inlet 160 of the filter 155 to the open end with the outlet 168 of the connector 166 using, for example, epoxy , a polyurethane resin, a cinoacrylate resin, a UV-curable acrylic adhesive, or a solvent for the 166 hollow connector material, such as cyclohexanone. In the illustrated embodiment, the open end with outlet 168 of connector 166 includes a hollow cylindrical member that fits internally and attaches to the open end with inlet 160 of filter 155. Accordingly, the outer diameter of the open end with outlet 168 of connector 166 is substantially similar or slightly smaller than the inside diameter of the open end with the inlet 160 of the filter 155. In some embodiments, the open end with the inlet 160 of the filter 155 may be welded to the open end with the outlet 168 of the connector 166 by, for example, heat welding (e.g., inserting a hot tapered metal tip into the open end with the inlet 150 of the filter 155 to partially melt it), laser welding if the hollow connector 166 is made of a material that absorbs laser radiation, mirror welding, ultrasonic welding, and friction welding. Alternatively, the filter 155 may be inserted into the mold and pressurized with a thermoplastic polymer around it to form the hollow connector 166. Other designs and configurations for attaching the filter 155 to the connector 166 are intended to be within the scope of the present invention.

[00080] The hollow connector 166 also includes a solution inlet 169. The pharmaceutical solution may be supplied through a connected fluid line, for example, to the solution inlet 169 of the hollow connector 166. In some embodiments, the solution inlet 169 may include Luer fitting or other standard medical fitting. The pharmaceutical solution can then pass through the hollow connector 166 and exit into the filter 155 through the open end with the outlet 168 of the hollow connector 166. The hollow connector 166 also has a sealing surface 172 to which a rod 156 is attached. The sealing surface 172 in this embodiment is cylindrical and has a diameter that is greater than the diameter of the outlet open end 168 and is generally concentric to the outlet open end 168. Indeed, in this embodiment, the outer diameter of the sealing surface 172 is generally identical or slightly less than the inner diameter of the stem 156. With this configuration, the rod 156 receives and exits the sealing surface 172, enclosing and protecting the filter 155 without contacting the surface 164 of the filter 155. The rod 156 can be attached to the sealing surface 172 with an adhesive (e.g., UV-curing acrylic adhesive), epoxy resin , welding, gluing, etc. The rod 156 receives the pharmaceutical solution after it passes through the pores 162 in the filter 155. From there, the already filtered solution enters the chamber 152.

[00081] FIG. 6-10 illustrate an alternative hollow connector 766, similar to connector 166, for attaching rod 156 and hollow fiber filter 155 of FIG. 3-5 together. Connector 766 includes an open end with an outlet 768 supported by a rod structure that extends in a first direction from a base plate 777 and is adapted to provide an open end leak tight connection with an inlet 160 of filter 155. This connection can be achieved by gluing the open end to the inlet 160 of the filter 155 to the open end with the outlet 768 of the connector 766 using, for example, an epoxy resin, a polyurethane resin, a cinoacrylate resin, a UV curable acrylic adhesive, or a solvent for the hollow connector 766 material, such as cyclohexanone. In the illustrated embodiment, the open end rod structure with outlet 768 of connector 766 comprises a hollow cylindrical member that is received internally and secured to the open end with inlet 160 of filter 155. Accordingly, the outer diameter of the open end with outlet 768 of connector 766 is substantially similar or slightly less than the inner diameter of the open end with the inlet 160 of the filter 155. In some embodiments, the open end with the inlet 160 of the filter 155 may be welded to the open end with the outlet 768 of the connector 766 by, for example, heat welding (e.g. tapered metal tip into the open end with inlet 150 of filter 155 to partially melt it), laser welding if the hollow connector 766 is made of a material that absorbs laser radiation, mirror welding, ultrasonic welding, and friction welding. Alternatively, the filter 155 may be inserted into a mold and pressurized with a thermoplastic polymer around it to form a hollow connector 766. Other structures and configurations for attaching the filter 155 to the connector 766 are intended to be within the scope of the present invention.

[00082] The hollow connector 766 also includes a solution inlet 769, which is also a rod structure extending in a second direction (opposite to the first direction) from the base plate 777. The pharmaceutical solution can be supplied through a connected fluid line, for example, into an inlet solution port 769 of hollow connector 766. In some embodiments, solution inlet 769 may include a Luer lock or other standard medical fitting. The pharmaceutical solution can then pass through the hollow connector 766 and out into the filter 155 through the open end with the outlet 768 of the hollow connector 766.

[00083] The hollow connector 766 also has a sealing surface 772 to which a rod 156 is attached. The sealing surface 772 in this embodiment is a cylindrical housing extending from the base plate 777 in a first direction and having a diameter greater than the diameter of the open end with an outlet 768. Sealing surface 772 is generally concentric with respect to the open end with outlet 768. Therefore, in this embodiment, the seal surface casing 772 surrounds the open end rod structure with outlet 768 such that an annular gap 779 is formed therebetween. in this embodiment, the outer diameter of the sealing surface 772 is usually the same as or slightly less than the inner diameter of the rod 156. With this configuration, the sealing surface 772 of the connector 766 can mate with the rod 156 so that the rod 156 protrudes from it and encloses and protects the filter 155 without contact to surface 164 of filter 155. Rod 156 may be attached to sealing surface 772 using an adhesive (eg, UV-curable acrylic adhesive), epoxy, welding, gluing, etc. The rod 156 receives the pharmaceutical solution after it passes through the pores 162 in the filter 155. From there, the already filtered solution passes into the chamber 152 in the same manner as described above with respect to FIG. 3-5.

[00084] While the aforementioned filter 155 has been described as including a single filter membrane 170, in other embodiments within the scope of the present invention, the filter 155 may include multiple filter membranes 170. Several examples of multiple membrane filters lacking restrictive, will be discussed below. Finally, as described in relation to product bags 100, 150 of FIG. 1-4, connector 166 in FIG. 5 may include a sterile closure cap 154 covering the solution inlet 168 to prevent contaminants from entering the product bag prior to filling.

[00085] In one embodiment, the next node of FIG. 5, and, as mentioned, the rod 156 has an inner diameter that is larger than the outer diameter of the filter membrane 170 and the rod 156 has a longitudinal dimension that is larger than the longitudinal dimension of the filter membrane 170. Therefore, when the rod 156 and the filter membrane 170 are assembled on connector 166, the filter membrane 170 is positioned entirely within the rod 156, and there is a gap between the inner side wall of the rod 156 and the outer side wall of the filter membrane 170. Therefore, the solution passing through the filter membrane 170 exits from the plurality of pores 162 and flows unhindered through this gap and along the inner surface of the rod 156 into the chamber. In some embodiments, shaft 156 may be flexible tubing, rigid tubing, or include tubing with flexible portions and rigid portions. In particular, in some embodiments, the rod 156 with at least one rigid portion adjacent to the filter membrane 170 may serve to further protect the filter membrane 170 and / or prevent the filter membrane 170 from puncturing or kinking at the flexible portion of the tubing. In other embodiments, such protection may not be required or desirable. In one embodiment, the rod 156 has an inner diameter in the range of about 2.5 mm to about 8 mm and a longitudinal dimension in the range of about 5 cm to about 30 cm. In one embodiment, the inner diameter of the rod 156 is about 0.2-3 mm larger than the outer diameter of the filter membrane 170. And the filter membrane 170 has an outer diameter in the range of about 2.3 mm to about 5 mm, a longitudinal dimension in the range of about 3 cm to about 20 cm, and a wall thickness in the range of about 150 microns to about 500 microns. Moreover, in one embodiment, each of the plurality of pores 162 in the filter membrane 170 has a diameter less than or equal to about 0.2 microns. In some embodiments, each pore has a diameter less than or equal to a value in the range of about 0.1 micron to about 0.5 micron, such as about 0.2 to about 0.4 micron. In some embodiments, each pore has a diameter less than or equal to about 0.22 microns. In some embodiments, each pore has a diameter that is less than or equal to a value in the range of about 0.1 micron to about 0.2 micron. In some embodiments, each pore has a diameter that is less than or equal to a value in the range of about 0.1 microns to about 0.22 microns. These pore sizes, combined with the disclosed geometric dimensions of the rod 156 and filter membrane 170, provide acceptable flow rates through the filter membrane 170 for filling product bags with injectable patient solutions such as sterile water, sterile saline, and the like. In other embodiments, any or all of the dimensions may vary depending on the particular application.

[00086] Suitable materials for the filter membrane 170 may include polyolefins (eg, PE, PP), polyvinylidene fluoride, polymethyl methacrylate, polyacrylonitrile, polysulfone, and polyethersulfone. In some embodiments, within the scope of the present invention, the filter 155 may be made from a mixture of polysulfone or polyethersulfone and polyvinylpyrrolidone. In other embodiments within the scope of the present invention, the filter membrane 170 may include a polymer containing cation charges, for example, polymers having functional groups such as quaternary ammonium groups. A suitable example of such polymers is polyethyleneimine. The filter membrane 170 can be manufactured using known techniques, including, for example, extrusion, phase inversion, extrusion, chemical vapor deposition, 3D printing, etc. Suitable materials for rod 156 include PVC, polyesters such as PET, poly (meth) acrylates such as PMMA, polycarbonates (PC), polyolefins such as PE, PP or cycloolefin copolymers (SCO), polystyrene (PS), organosilicon polymers and the like

[00087] Further details of some possible filter options and a particular membrane design, for example, are found in European patent application No. EP 16152332.9 entitled "FILTER MEMBRANE AND DEVICE", which was filed January 22, 2016, as well as in PCT / EP2017 / 051044 entitled "FILTER MEMBRANE AND DEVICE" filed January 19, 2017, the entire content of each of which is expressly incorporated herein by reference.

[00088] So far, the hollow fiber membrane 170 of FIG. 5, for example, has been described as being located within the rod 156. In other embodiments, the filter 155 may have its own housing or other support structure coupled to the rod 156 or instead of the connector 166 of FIG. 5 or connector 766 of FIG. 6-10, or in the area between the two parts of the rod 156.

[00089] For example, in FIG. 11 illustrates a front view of a product bag filter assembly 400 (not shown) having a single U-shaped hollow fiber filter membrane 402 contained within a filter housing 404. The filter membrane 402 is attached to a filter membrane housing 406 in a U-shaped configuration using an adhesive ( i.e. UV-curable acrylic glue), epoxy, welding, gluing, or other means. The filter membrane housing 406 is connected to the filter housing 404 at the outlet 408 of the filter housing 404. The inlet portion 410 is sealed to the outlet 408 of the filter housing 404 at a mating or other junction. The inlet portion 410 of the filter housing 404 has an inlet 412 through which the pharmaceutical solution can enter the filter assembly 400. The pharmaceutical solution then enters the filter membrane 402 through the plurality of pores 414, passes through the filter membrane 402, exits the filter membrane 402 through the outlets filter membrane 416 and exits filter housing 404 through filter outlet 418. Filter outlet 418 may then be connected to a chamber (not shown) via rod 256 of a product bag (not shown). FIG. 11, the flow of liquid through assembly 400 has been described as going from inlet 412 at inlet 410 to outlet 418 at outlet 408. However, the same assembly 400 can be used in the opposite direction such that liquid enters through the outlet. opening 418 at outlet 408 and exits through inlet 412 at inlet 410. In this alternative configuration, liquid first enters inlet 418, enters filter membrane 402 through outlets of filter membrane 416 and exits through pores 414 and finally, inlet 412.

[00090] FIG. 12 illustrates an alternative implementation of the filter assembly 400 illustrated in FIG. 11. In FIG. 12, filter 420 contains two U-shaped hollow fiber filter membranes 422 attached to the body of filter membranes 424 in a U-shaped configuration using an adhesive (i.e., UV-curable acrylic adhesive), epoxy, welding, gluing, or some other means. ... The filter membranes 422 and the filter membrane housing 424 are located within the filter housing 426 having an inlet portion 428 with an inlet 430 sealed to an outlet portion 432 with a filter outlet 434. In other embodiments, the filter may comprise more than two U- shaped hollow fiber filter membranes arranged as illustrated in FIG. 11 and 12. FIG. 12 as in FIG. 11, fluid flow through assembly 400 has been described as moving from inlet portion 428 to outlet portion 432. However, the same assembly 400 can be used in the opposite direction such that fluid enters through outlet portion 432 and exits through portion with inlet 428 as described above with respect to FIG. eleven.

[00091] FIG. 13 illustrates yet another alternative filter assembly. In particular, in FIG. 13, a plurality of in-line membrane filters 502 are connected directly to each other in a parallel side-by-side configuration to form what may be referred to as a fiber bundle. Filters 502 in FIG. 13 can be bonded together with an adhesive (i.e., UV-curable acrylic glue), epoxy, welding, gluing, and the like. In other embodiments, a plurality of filters 502 may be manufactured together as a single product using any of the manufacturing techniques described above.

[00092] FIG. 14 illustrates yet another alternative, in which an attachment device 504 includes a series of blocks defining a plurality of slots 506, identical to the number of hollow fiber membrane filters 502. These attachment blocks 504 may be bonded together to form a multilayer structure and used to retain a plurality of hollow fiber membrane filters 502 in a side-by-side configuration. The attachment device 504 illustrated in FIG. 14 allows two sets of hollow fiber membrane filters 502 to be positioned according to FIG. 13 relative to each other. A fiber bundle including membrane filters 502 and attachment device 504 may be housed in the filter housing in the manner described in relation to FIG. 11 and 12.

[00093] FIG. 15 illustrates an isometric view of yet another embodiment of a fiber bundle 600 for a product bag (not shown) having a plurality of parallel hollow fiber membrane filters 502 similar to FIG. 13 and 14, but characterized in that the parallel filters 502 are arranged in a circle and are held by an annular holder 504. The fiber bundle 600 can be placed in the filter housing in the manner described in relation to FIG. 11 and 12.

[00094] FIG. 16-17 as well as FIG. 18-20 illustrate two additional devices for attaching fiber bundles to a rod in accordance with the present invention. FIG. 16-17 illustrate a connector 866 for attaching a three-fiber bundle to a rod. In particular, connector 866 includes a first hollow body 866a and a second hollow body 866b. The first body 866a includes a solution inlet 869, which is the structure of a rod extending from the support plate 877. The pharmaceutical solution may be supplied through a connected fluid line, for example, into the solution inlet 869 of the first hollow body 866a of the connector 866. In some In options, the solution inlet 869 may include a Luer lock or other standard medical fitting.

[00095] The hollow connector 866 also has a sealing surface 872 to which a rod 156 is attached. The sealing surface 872 in this embodiment is a cylindrical housing extending from the base plate 877 in the opposite direction to the direction of the solution inlet 869. The sealing surface 872 is located generally concentrically with respect to the solution inlet 869. Therefore, in this embodiment, the seal surface shroud 872 defines a cylindrical cavity (not shown) for receiving a portion of the second hollow body 866b of the connector 866.

[00096] The second hollow body 866b, as illustrated, includes a base plate 880 and three open ends with outlets 868 protruding from the base plate 880. In addition, the base plate 880 has an outer diameter that is generally the same or slightly smaller the inner diameter of the casing cavity of the sealing surface 872, such that when assembled, the support plate 880 is located in the cavity. In one embodiment, the backing plate 880 includes a sealing member 882 that extends circumferentially to form a watertight seal with the inner surface of the housing of the sealing surface 872 when inserted into the cavity. Friction, adhesive, or some other means may hold the backing plate 880 in conjunction with the seal surface housing 872.

[00097] As mentioned, second body 866b includes three open ends 868 extending from base plate 880. Each open end 868 is adapted to seal open end to inlet 160 of one of three filters 155. This connection can be achieved by adhering the open ends with the inlets 160 of the filters 155 to the open ends with the outlets 868 using, for example, an epoxy resin, a polyurethane resin, a cinoacrylate resin, a UV curable acrylic adhesive, or a solvent for the 766 hollow connector material, such as cyclohexanone. In the illustrated embodiment, the open-ended rod structure with outlets 868 of the connector 866 comprises a hollow cylindrical member that fits internally and attaches to the open ends with inlets 160 of filters 155. Accordingly, the outer diameter of the open ends with outlets 868 is substantially the same or slightly less than the inside diameter of the open ends 160 of the filters 155. In some embodiments, the filters 155 may be welded to the open ends 868 of the connector 866 by, for example, heat welding (e.g., introducing a hot tapered metal tip into the open ends with the inlets 150 filters 155 to partially melt them), laser welding if the hollow connector 866 is made of a material that absorbs laser radiation, mirror welding, ultrasonic welding and friction welding. Alternatively, filters 155 can be inserted into a mold and thermoplastic resin can be injected around them to form hollow connector 866. Other designs and configurations for attaching filters 155 to open ends with outlets 868 are intended to be within the scope of the present invention.

[00098] Finally, as in the embodiments previously described, the sealing surface 872 of the connector 866 can be received by the rod 156 such that the rod 156 extends therefrom to enclose and protect the filters 155 without contacting the surfaces 164 of the filters 155. The rod 156 can be attached to the sealing surface 872 using an adhesive (eg, UV-curable acrylic adhesive), epoxy, welding, gluing, etc. The rod 156 receives the pharmaceutical solution after the solution has passed through the pores 162 in the filter 155. From there, the already filtered solution passes into the chamber 152 in the same manner as described above with respect to FIG. 3-5.

[00099] FIG. 18-20 illustrate connector 966 for attaching a seven-fiber bundle to a rod. In particular, connector 966 includes a first hollow body 966a and a second hollow body 966b, which can be attached to the first hollow body 966a by adhesive or other means. The first body 966a includes a solution inlet 969, which is the structure of a rod extending from the base plate 977. The pharmaceutical solution may be supplied through a connected fluid line, for example, into the solution inlet 969 of the first hollow body 966a of the connector 966. In some Options, the solution inlet 969 may include a Luer lock or other standard medical fitting.

[00100] The second hollow body 866b, as illustrated, includes a hollow cylindrical support collar 980 in which seven hollow fiber membrane filters 955 may be arranged parallel to each other, as illustrated in FIG. 18 and 20. In one embodiment, the support collar 980 may include a support plate 982 carrying seven open ends with outlets 968 entering the collar 980 for attaching to filters 955 in a manner similar to that described above with respect to FIG. 16-17. This connection can be achieved by adhering filters 955 to the open ends with outlets 968 using, for example, epoxy resin, polyurethane resin, cinoacrylate resin, UV-curable acrylic adhesive, or a solvent for the 966 hollow connector material such as cyclohexanone. In the illustrated embodiment, the open-ended rod structure with outlets 868 of the connector 866 comprises a hollow cylindrical member that fits internally and attaches to the filters 955. Accordingly, the diameter of the open ends with the outlets 968 is substantially the same or slightly smaller than the internal diameter of the filters 955. In some embodiments, the filters 955 can be welded to the open ends 968 of the connector 966 by, for example, heat welding (for example, inserting a hot tapered metal tip into the filters 955 to partially melt them), laser welding if the hollow connector 966 is made of material that absorbs laser radiation, mirror welding, ultrasonic welding and friction welding. Alternatively, filters 955 may be inserted into a mold and pressurized with thermoplastic resin around them to form hollow connector 966. Other designs and configurations for attaching filters 955 to open ends with outlets 968 are intended to be within the scope of the present invention.

[00101] Finally, the sleeve 980 of this embodiment includes a sealing surface 972 that can be received by the rod 156 so that the rod 156 exits therefrom. The rod 156 can be attached to the sealing surface 972 with an adhesive (eg, UV-curable acrylic glue), epoxy, welding, gluing, etc. The rod 156 receives the pharmaceutical solution after the solution passes through the pores 162 in the filters 955. From there, the already filtered solution passes into the chamber 152 in the same manner as described above with respect to FIG. 3-5.

[00102] In some embodiments within the scope of the present invention, more than one product bag may be filled with a single filter. FIG. 21 illustrates a multi-bag filling kit containing three bags for product 200a, 200b and 200c (but could contain any number or many bags of product), similar to product bags 100 and 150, except that they are in series. and a single filter 206 is used to fill all three product bags 200a, 200b and 200c in turn (i.e., sequentially). As with product bags 100 and 150, product bags 200a, 200b, and 200c have injection ports 204a, 204b, and 204c, and may also include drug ports (not shown). Cameras 202a, 202b and 202c are connected at edges 206a and 206b. The edges 206a, 206b each have an opening 208a and 208b, and the openings 208a, 208b provide a fluid connection of all three chambers 202a, 202b and 202c to each other. One of the chambers 202a has an inlet 210 that is connected to the rod 212 and the filter 206. The rod 212 and the filter 206 of FIG. 21 can be located in any of the ways described above. During use, the filtered solution passes through the rod 212 and through the filter 206, enters the inlet 210, passes through the openings 208a and 208b, and ultimately fills all three chambers 202a, 202b and 202c. Depending on the particular arrangement of the product bags 200a, 200b, 200c, chambers 202a, 202b, 202c may be filled sequentially or simultaneously during the filling process. For example, if product bags 200a, 200b, 200c are positioned as illustrated in FIG. 21, their chambers 202a, 202b, 202c will be filled simultaneously as solution is fed through inlet 210. But if the product bags 200a, 200b, 200c are rotated ninety degrees counterclockwise from their position illustrated in FIG. 21, chamber 202a will fill first, then chamber 202b will fill, and then finally chamber 202c will be filled last. After chambers 202a, 202b, and 202c have been filled, inlet 210 and openings 208a and 208b can be sealed. The edges can then be cut to separate the three product bags 200a, 200b and 200c.

[00103] FIG. 22 illustrates a multi-bag filling kit comprising three product bags 300a, 300b, and 300c connected by a tight tubing 302 to a single filter 304, which may be one of the filters discussed above. The first portion 306 of the tight tube system 302 is connected to a filter 304 or a rod (not shown) surrounding the filter 304. The first portion 306 of the tight tube system 302 extends to a junction 308 to which a plurality of second portions 310 of the tight tube system 302 are connected by their respective first ends 312. Each second portion 310 is connected at a second end 314 to a respective chamber 316 of product bags 300a, 300b and 300c. After each chamber 316 is filled, the second portion 310 of the tight-fitting tubing 302 can be sealed and cut off. In the configuration illustrated in FIG. 22, liquid may be supplied to filter 304 and into product bags 300a, 300b, 300c through second portions 310 of tight-fitting tubing 302. In one embodiment, liquid may be supplied generally simultaneously and in generally uniform batches from filter 304 to second portions 310 the system of tight-fitting tubes 302, thus generally simultaneously filling each of the product bags 300a, 300b, 300c. In other embodiments, the liquid may be dispensed as a whole sequentially into different product bags 300a, 300b, 300c. For example, liquid can flow from the filter 304 into the first product bag 300a, valves (not shown) associated with the second and third product bags 300b, 300c are closed. After filling the first bag 300a, a valve (not shown) of the first bag 300a may be closed and a valve associated with the second bag 300b may be opened to allow filling of the second bag 300b. After filling the second bag 300b, the valve (not shown) of the second bag 300b can be closed and the valve associated with the third bag 300c can be opened to allow the third bag 300c to be filled. Finally, after filling the third bag 300c, the valve (not shown) of the third bag 300c can be closed. The valves associated with the bags 300a, 300b, 300c may be located on the second portions 310 of the tight-fitting tube system 302 associated with each of the bags 300a, 300b, 300c, or on the bags 300a, 300b, 300c themselves. In yet another embodiment, the system may include a single three-way valve located at connection 308 to direct fluid to and from the various bags 300a, 300b, 300c.

[00104] FIG. 23 illustrates a two-bag continuous ambulatory peritoneal dialysis (CAPD) container system 1002 containing a solution bag 1004 and a drainage bag 1006. Solution bag 1004 provides an injection field 1008 for adding drugs. Tubing 1010 extends from solution bag 1004 to filter tee 1012 and then to patient connector 1014. Connecting tubing 1016 (i.e., stem) connects a filter assembly 1018, such as any of those described above, to filter tee 1012 and sequentially to the solution bag 1004. Tubing 1010 may have a fragile portion 1020 near the patient connector 1014. In other embodiments, the fragile portion 120 may be located closer to the tee 1020 or midway between the tee 1020 and the patient connector 1014. The tubing 1022 extends from the drainage bag 1006 to patient connector 1014. Patient connector 1014 is configured to interface with a patient's peritoneal dialysis (PD) catheter transfusion system (not shown) during use. The patient connector 1014 has a tee 1024 that connects the tube 1010 and the tube 1022. The patient connector 1014 has a protective cap to ensure sterility 1026.

[00105] FIG. 24, a two-bag CAPD container system 1002 is illustrated, similar to the system illustrated in FIG. 23, except that there is no filter tee 1012. Instead, the connecting tube 1016 (i.e., the rod) is connected directly to the solution bag 1004. FIG. 24, a connecting tube 1016 is attached to the solution bag 1004 between the tube 1010 and the injection field 1008, but this is just one example and other arrangements are possible.

[00106] The filter assembly 1018 illustrated in FIG. 23 and 24 can be any of the filter assemblies discussed above. For example, the filter assembly 1018 may be a filter 106 having a flat membrane plate 142 of FIG. 1 and 2, or filter 155, which is the hollow fiber membrane of FIG. 3-5 secured by a connector 166 or 766. Filter assembly 1018 may be a filter assembly 400 having a single U-shaped hollow fiber filter membrane 402 located within filter housing 404 of FIG. 11, or an alternative filter assembly 400 consisting of two U-shaped hollow fiber filter membranes 422 of FIG. 12. The filter assembly may be a plurality of in-line membrane filters 502 mounted side-by-side, as illustrated in FIG. 13, optionally with the attachment device 504 of FIG. 14, or the tow 600 of FIG. 16, optionally held together by any connector such as 866 or 966.

[00107] While certain representative variations of the claimed subject matter have been described herein for the purpose of illustrating the invention, those skilled in the art will appreciate that various changes may be made to the devices and methods disclosed herein without departing from the spirit and scope of the invention. which is defined by the following claims and is in no way limited by the above description.

Claims (36)

1. A set for filling a bag for a sterile solution of the product, containing: a plurality of chambers in fluid communication with each other at least in part through a tubing system; a rod having an inlet end and an outlet end, the outlet end of the rod being in fluid communication with the plurality of chambers; and a filter located coaxially with a rod, the filter having at least one filter membrane with a nominal pore size in the range of 0.1 to 0.5 μm, and a rod and filter in fluid communication with a tubing system and a plurality of chambers for filling the filling set a product bag for a sterile solution, the tubing consisting of a first part that extends from the rod and a plurality of second parts that extend from the first part to a plurality of chambers, each second part extending to one chamber. 2. A set for filling a bag for a sterile product solution according to claim 1, characterized in that at least one filter membrane is located inside the rod between the ends with inlet and outlet openings. 3. Set for filling a bag for a sterile solution of the product according to any one of paragraphs. 1, 2, characterized in that the filter consists of a plurality of filter membranes. 4. A set for filling a bag for a sterile solution of the product according to any one of paragraphs. 1, 2, characterized in that at least one filter membrane has a wall thickness in the range from 150 to 500 μm. 5. Set for filling a bag for a sterile solution of the product according to any one of paragraphs. 1, 2, characterized in that at least one filter membrane has a longitudinal dimension in the range of 3 to 20 cm, an inner diameter in the range of 2 to 4 mm and an outer diameter in the range of 2.3 to 5 mm. 6. Set for filling a bag for a sterile solution of the product according to any one of paragraphs. 1, 2, characterized in that at least one filter membrane is made of at least one of the following materials: polyolefin, polyvinylidene fluoride, polymethyl methacrylate, polyacrylonitrile, polysulfone, polyethersulfone and a polymer containing cation charges. 7. A set for filling a bag for a sterile solution of the product according to any one of paragraphs. 1, 2, characterized in that the rod is either flexible or rigid. 8. Set for filling a bag for a sterile solution of the product according to any one of paragraphs. 1, 2, characterized in that the rod is made of at least one of the following materials: PVC, PET, poly (meth) acrylate, polycarbonate, polyolefin, cycloolefin copolymer, polystyrene or silicone polymer. 9. Set for filling a bag for a sterile solution of the product according to any one of paragraphs. 1, 2, characterized in that the filter includes at least one U-shaped hollow fiber filter membrane secured in a U-shaped configuration by a filter membrane housing located inside the filter housing. 10. The kit for filling a bag for a sterile product solution according to claim 9, wherein the filter includes a plurality of U-shaped hollow fiber filter membranes. 11. Set for filling a bag for a sterile solution of the product according to any one of paragraphs. 1, 2, characterized in that the filter consists of a plurality of parallel hollow fiber membrane filters fixed in a side-by-side configuration. 12. Set for filling a bag for a sterile solution of the product according to any one of paragraphs. 1, 2, characterized in that the filter consists of a plurality of parallel hollow fiber membrane filters arranged in a circle. 13. Set for filling a bag for a sterile solution of the product according to any one of paragraphs. 1, 2, characterized in that at least one filter membrane has a nominal pore size in the range from 0.1 to 0.22 μm. 14. Set for filling a bag for sterile product solution, containing: a plurality of chambers in fluid communication with each other at least in part through a tubing system; a rod having an inlet end and an outlet end, the outlet end of the rod being in fluid communication with the at least one chamber; a filter including at least one porous filter membrane located inside the rod, a rod and a filter in fluid connection with the tubing system and a plurality of chambers for filling a set for filling a bag for a sterile product solution, the tubing system consisting of a first part, which extends from the rod, and a plurality of second portions that extend from the first portion to a plurality of chambers, each second portion extending to one chamber; a connector connected to a rod end with an inlet and an open end of the filter, the connector has a solution inlet, a solution outlet and a sealing surface located between the solution inlet and the solution outlet, the solution outlet is connected to the open end filter, and the sealing surface is connected to the end of the rod with the inlet, the inlet for the solution is adapted to receive the solution for filtration through the rod and the plurality of chambers. 15. The kit for filling a bag for a sterile product solution according to claim 14, characterized in that at least one porous filter membrane has a nominal pore size in the range from 0.1 to 0.5 μm. 16. The kit for filling a bag for a sterile product solution according to claim 15, characterized in that at least one filter membrane has a nominal pore size in the range from 0.1 to 0.22 μm. 17. Set for filling a bag for a sterile solution of the product according to any one of paragraphs. 14-16, characterized in that the end of the inlet rod is attached to the sealing surface of the connector, and the open end of the filter is attached to the outlet of the solution connector. 18. Set for filling a bag for a sterile solution of the product according to any one of paragraphs. 14-16, characterized in that the outlet of the solution connector comprises a cylindrical element located inside the open end of the filter. 19. Set for filling a bag for a sterile solution of the product according to any one of paragraphs. 14-16, characterized in that the filter consists of a plurality of filter membranes. 20. Set for filling a bag for a sterile solution of the product according to any one of paragraphs. 14-16, characterized in that at least one filter membrane has a wall thickness in the range from 150 to 500 μm. 21. Set for filling a bag for a sterile solution of the product according to any one of paragraphs. 14-16, characterized in that at least one filter membrane has a longitudinal dimension in the range of 3 to 20 cm, an inner diameter in the range of 2 to 4 mm and an outer diameter in the range of 2.3 to 5 mm. 22. A set for filling a bag for a sterile solution of the product according to any one of paragraphs. 14-16, characterized in that at least one filter membrane is made of at least one of the following materials: polyolefin, polyvinylidene fluoride, polymethyl methacrylate, polyacrylonitrile, polysulfone, polyethersulfone and a polymer containing cation charges. 23. Set for filling a bag for a sterile solution of the product according to any one of paragraphs. 14-16, characterized in that the rod is either flexible or rigid. 24. Set for filling a bag for a sterile solution of the product according to any one of paragraphs. 14-16, characterized in that the rod is made of at least one of the following materials: PVC, PET, poly (meth) acrylate, polycarbonate, polyolefin, cycloolefin copolymer, polystyrene or silicone polymer. 25. Set for filling a bag for a sterile solution of the product according to any one of paragraphs. 1, 2 and 14-16, characterized in that the set for filling a bag for a sterile solution product is part of a container system for continuous ambulatory peritoneal dialysis (CAPD) with two bags, which, in turn, consists of a drainage bag and a connector a patient with a tee connected to a first tube connected to a product bag filling set and a second tube connected to a drainage bag. 26. A set for filling a bag for a product for a sterile solution according to claim 25, characterized in that an injection field is provided on the set for filling a bag for a product. 27. A set for filling a bag for a sterile product solution according to claim 25, characterized in that the first tube connected to the set for filling a bag for a product has a fragile portion. 28. The kit for filling a bag for a sterile product solution according to claim 25, wherein the patient connector has a protective cap to ensure sterility. 29. A set for filling a bag for a sterile product solution according to claim 25, characterized in that the outlet of the rod is connected to a tee located along the first tube connected to the set for filling the bag for a product.

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